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Application 203923
- Type
- NDA
- Sponsor
- HOPE PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SODIUM THIOSULFATE | SODIUM THIOSULFATE | SOLUTION;INTRAVENOUS | 12.5GM/50ML (250MG/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 60267-705 | Sodium Thiosulfate | Sodium Thiosulfate | Hope Pharmaceuticals | NDA | Current |
| 60267-705 | Sodium Thiosulfate | Sodium Thiosulfate | Hope Pharmaceuticals | NDA | Current |
| 60267-705 | Sodium Thiosulfate | Sodium Thiosulfate | Hope Pharmaceuticals | NDA | Current |
| 60267-705 | Sodium Thiosulfate | Sodium Thiosulfate | Hope Pharmaceuticals | NDA | Current |
| 60267-705 | Sodium Thiosulfate | Sodium Thiosulfate | Hope Pharmaceuticals | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 63669 | SUPPL | 2020-06-23 |
| 63666 | SUPPL | 2020-06-23 |
| 63659 | SUPPL | 2020-06-22 |
| 50158 | SUPPL | 2017-10-24 |
| 50132 | SUPPL | 2017-10-23 |
| 24452 | ORIG | 2012-03-15 |
| 22937 | ORIG | 2012-03-15 |
| 32479 | ORIG | 2012-02-21 |
| 19503 | ORIG | 2012-02-17 |